Associate Vice President - Women’s Health & Early Clinical Development

At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We’re looking for people who are determined to make life better for people around the world.

Position Summary:

The Associate Vice President (AVP), Women’s Health & Early Clinical Development, serves as a pivotal leader responsible for establishing and advancing Lilly's Women's Health portfolio. We are looking for a dynamic and strategic leader with deep understanding of women’s health physiology, pathophysiology and clinical care, and a passion for developing new medicines to advance women’s health. The ideal candidate will have a track record of impactful translational and/or clinical research related to women’s health, and a demonstrated ability to progress new medicines as part of a drug development team. Responsibilities of the role include directing research and clinical development programs through Phase 2, liaising with drug discovery scientists, external innovation, late phase development and commercial colleagues to evaluate and progress new therapeutic opportunities, and advancing external collaborations and strategic partnerships to drive impactful outcomes for women’s health. The AVP will shape and execute strategies for both internal and external portfolio growth, and will collaborate closely with enterprise leaders to align scientific research and development with overarching company objectives.

We are seeking a candidate with an MD or MD/PhD in gynecology or reproductive endocrinology, who specializes in the health of the female reproductive system and has provided comprehensive care for conditions including menstrual disorders, preeclampsia, infertility, menopause, and osteoporosis. Experience as a clinical researcher in academia or expertise in pharmaceutical drug development is essential.

Position Responsibilities:

Portfolio Strategy and Clinical Planning

• Shape Lilly’s strategy in Women’s Health by combining a deep understanding of current therapeutic landscape and competitive environment with evaluation of internal and external opportunities to build an industry-leading portfolio.
• Develop project concepts, investment strategies and clinical development plans that that allow for efficient assessment of new therapeutic approaches and targets
• Collaborate with new product planning to develop and maintain Draft Launch Labels and Value Propositions that address key customer needs
• Contribute to and lead innovative drug discovery and development projects
• Serve as medical expert in interactions with external partners and during assessment of business development opportunities

Clinical Research, Trial Execution and Support

• Collaborate with clinical research staff in design, conduct and reporting of clinical trials
• Review and approve risk profiles to ensure appropriate communication to study subjects
• Assist in planning and participate in study start-up meetings and other activities to provide the appropriate training and information to investigators and site personnel.
• Participate in investigator identification and selection
• Ensure that operational team has documented the completion of administrative requirements for study initiation and conduct consistent with Good Clinical Practices and local laws and requirements.
• Serve as resource to clinical operations personnel / clinical research monitors, investigators and ethical review boards to address any questions or clarify issues arising during the conduct of study.
• Understand and actively address the scientific information needs of all investigators and personnel.
• Monitor patient safety during the conduct of studies and conduct the appropriate tracking and follow-up of adverse events
• Knowledge of clinical research methodology including latest developments in relevant areas of biomarkers, efficacy measures, diagnostic practices, study designs, safety evaluations and regulatory standards.

Regulatory Support Activities

• Support / assist in the preparation of regulatory reports, including INDs, FDA annual reports, regulatory responses and Periodic Adverse Drug Experience Reports (PADERS), preparation for FDA communication and resolution of regulatory issues, including regulatory response, from a global perspective. Provide medical expertise to regulatory scientists.

• Participate in face-to-face meetings with FDA, EMEA and other regulatory bodies
• Participate in risk management planning along with affiliates and Global Patient Safety.

Data Dissemination and Scientific Exchange

• Participate in data analysis and preparation of final reports and publications. Prepare or review scientific information in response to internal or external questions.
• Participate in and lead scientific disclosures and publications.
• Support and lead the planning of symposia, advisory board meetings, and other meetings with health care professionals.
• Establish and maintain appropriate collaborations and relationships with external experts, thought leaders, and the general medical community on a national and international basis.
• Represent Lilly in external forums where standards, common protocols, assessment instruments, regulatory standards and clinical practice guidelines relevant to women’s health are discussed
• Develop and maintain appropriate collaborations and relationships with relevant professional societies.
• Knowledge of and compliance with local laws and regulations, and global policies and procedures, compliance guidelines with respect to data dissemination and interactions with external health care professionals.

Scientific / Technical Expertise and People Development        

• Maintain and disseminate within Lilly information on latest developments in the pathophysiology, diagnosis, etiology, treatment and management of women’s health. Critically read and evaluate the relevant medical literature.
• Be aware of current trends and projections for clinical practice and access in the therapeutic area(s) relevant to the priority areas
• Actively set and meet individual professional development goals
• Contribute to the development of others by acting as mentor and coach to co-workers

Basic Qualifications:

• MD or MD/PhD. Must be board eligible or certified as gynecologist or reproductive endocrinologist or have completed the comparable level of post-medical school clinical training relevant to the country of hiring.
• Clinical trialist with a track record of developing clinical plans and execution of studies in the pharmaceutical industry
• Minimum of five years experience in clinical research/drug development in academia or industry including the design and implementation of large global clinical trials.
• Minimum of five years experience in clinical practice with at least 2 years in Women’s health.
• Qualified candidates must be legally authorized to be employed in the United States.

Additional Skills/Preferences:

• Team-player with proven ability to shape project direction and influence stakeholders
• Demonstrated ability to drive for results in a fast-paced matrixed environment Innovation mindset with a passion for novel therapies
• Strong business acumen and strategic planning and execution skills
• Excellent written and verbal communication skills

Physical Demands/ Travel:

The physical demands of this job are consistent with light office duties. Up to 20% US/Global travel.

Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce, ensuring equal opportunities when vying for positions. If you require accommodation to submit a resume for a position at Lilly, please complete the accommodation request form (https://careers.lilly.com/us/en/workplace-accommodation) for further assistance. Please note this is for individuals to request an accommodation as part of the application process and any other correspondence will not receive a response.

Lilly is proud to be an EEO Employer and does not discriminate on the basis of age, race, color, religion, gender identity, sex, gender expression, sexual orientation, genetic information, ancestry, national origin, protected veteran status, disability, or any other legally protected status.

Our employee resource groups (ERGs) offer strong support networks for their members and are open to all employees. Our current groups include: Africa, Middle East, Central Asia Network, Black Employees at Lilly, Chinese Culture Network, Japanese International Leadership Network (JILN), Lilly India Network, Organization of Latinx at Lilly (OLA), PRIDE (LGBTQ+ Allies), Veterans Leadership Network (VLN), Women’s Initiative for Leading at Lilly (WILL), enAble (for people with disabilities). Learn more about all of our groups.

Actual compensation will depend on a candidate’s education, experience, skills, and geographic location.  The anticipated wage for this position is

$291,000 - $453,200

Full-time equivalent employees also will be eligible for a company bonus (depending, in part, on company and individual performance). In addition, Lilly offers a comprehensive benefit program to eligible employees, including eligibility to participate in a company-sponsored 401(k); pension; vacation benefits; eligibility for medical, dental, vision and prescription drug benefits; flexible benefits (e.g., healthcare and/or dependent day care flexible spending accounts); life insurance and death benefits; certain time off and leave of absence benefits; and well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities).Lilly reserves the right to amend, modify, or terminate its compensation and benefit programs in its sole discretion and Lilly’s compensation practices and guidelines will apply regarding the details of any promotion or transfer of Lilly employees.

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